Alupent

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

• Alupent^®

Fatalities have been reported following excessive use of Alupent (metaproterenol sulfate USP) as with other sympathomimetic inhalation preparations, and the exact cause is unknown. Cardiac arrest was noted in several cases.

Alupent (metaproterenol sulfate) , like other beta adrenergic agonists, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or ECG changes. As with other beta adrenergic aerosols, Alupent (metaproterenol sulfate) can produce paradoxical bronchospasm (which can be life threatening). If it occurs, the preparation should be discontinued immediately and alternative therapy instituted.

Alupent (metaproterenol sulfate) should not be used more often than prescribed. Patients should be advised to contact their physician in the event that they do not respond to their usual dose of a sympathomimetic amine aerosol.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of metaproterenol oral solution and tablets in children younger than 6 years of age. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of metaproterenol in geriatric patients.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Iobenguane I 123

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes or
• Heart or blood vessel disease or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Seizures—Use with caution. May make these conditions worse.

• Heart rhythm problems (e.g., arrhythmia) or
• Tachycardia (fast or rapid heartbeat)—Should not be used in patients with these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Fast, pounding, or irregular heartbeat or pulse

• Shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet
• worsening of asthma

• Blurred vision
• chest pain
• chills
• cough
• diarrhea
• dizziness
• fainting
• fever
• general feeling of discomfort or illness
• headache
• increased sweating
• joint pain
• loss of appetite
• muscle aches and pains
• nausea
• nervousness
• pounding in the ears
• puffiness of the face and fingers
• runny nose
• shivering
• slow or fast heartbeat
• sore throat
• sweating
• swelling
• trouble sleeping
• unusual tiredness or weakness
• vomiting

Get emergency help immediately if any of the following symptoms of overdose occur:

• Arm, back, or jaw pain
• chest discomfort
• chest tightness or heaviness
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• general feeling of discomfort or illness
• shortness of breath
• sleeplessness
• unable to sleep

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach pain

• Bad, unusual, or unpleasant (after) taste
• change in appetite
• drowsiness
• dry mouth or throat
• itching skin
• pain
• raised red swellings on the skin, lips, tongue, or in the throat
• tightening of the muscles
• weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Alupent® (metaproterenol sulfate USP) is indicated as a bronchodilator for bronchial asthma and for reversible bronchospasm which may occur in association with bronchitis and emphysema.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Applies to metaproterenol: compounding powder, inhalation aerosol, inhalation aerosol with adapter, inhalation solution, oral syrup, oral tablet

General

Metaproterenol (the active ingredient contained in Alupent) has been usually well-tolerated and adverse effects that occurred were consistent with its pharmacological activity. Additionally, partial or complete tolerance may develop to these side effects. In general, the severity of these effects are dependent on the dose and the route of administration. Metaproterenol given by metered dose inhaler (MDI) is associated with less systemic effects than administration of higher dosages orally or by nebulizer.[Ref]

Cardiovascular

Cardiovascular side effects have included palpitations and peripheral vasodilation, commonly resulting in reflex tachycardia. This may be caused by the interaction of metaproterenol (the active ingredient contained in Alupent) with beta-1 and beta-2 receptors. Blood pressure may increase or decrease. Metaproterenol in higher dosages may rarely aggravate angina, myocardial ischemia, or cause atrial or ventricular arrhythmias.[Ref]

Musculoskeletal

Musculoskeletal side effects have included tremors. Tolerance often develop to the tremorogenic effects following prolonged use of this medication. Severe muscle cramping may occur infrequently.[Ref]

Metabolic

The hypokalemic effect is due to the stimulation of beta-2 receptors that are linked to sodium-potassium ATPase in skeletal muscles, resulting in an intracellular influx of potassium.[Ref]

Metabolic side effects have included hypokalemia, hypophosphatemia, hyperglycemia, and elevations in plasma insulin.[Ref]

Nervous system

Nervous system side effects have included restlessness, nervousness, anxiety, irritability, headache, dizziness, and insomnia.[Ref]

Other

Other side effects have included the development of tachyphylaxis to the bronchodilating effects of metaproterenol (the active ingredient contained in Alupent) Although conflicting data exist, complete clinical tolerance has not been observed.[Ref]

Hypersensitivity

A 25-year-old woman respiratory therapist with a history of an itchy dermatitis on the face, neck, and upper extremities showed a positive reaction to metaproterenol (the active ingredient contained in Alupent) on skin patch testing.[Ref]

Hypersensitivity side effects have included rare reports of dermatitis.[Ref]

Respiratory

Respiratory side effects have included pulmonary edema in pregnant patients receiving the drug intravenously.[Ref]

Some side effects of Alupent may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.